Avanir Pharmaceuticals, a biopharmaceutical company focused on central nervous system disorders of high unmet medical need, has submitted a NDA to the FDA for approval of AVP-825, its innovative Breath Powered investigational drug-device combination product for the acute treatment of migraine.

The company's 505(b)(2) NDA for AVP-825 includes data from one pivotal phase III clinical trial for the acute treatment of migraine. The NDA also is supported by data from a phase II placebo-controlled clinical trial for acute treatment of migraine, and two pharmacokinetic studies. Overall, the submission includes safety data from 222 subjects who received AVP-825 in clinical trials, and references data from the extensive clinical use of sumatriptan over the past 20 years.

"The AVP-825 NDA submission represents an important milestone for Avanir," said Joao Siffert, M.D., chief scientific officer at Avanir. "If approved by the FDA, AVP-825 could meet a key unmet need by providing patients with a unique device that efficiently delivers a low dose of sumatriptan powder, providing rapid relief of migraine headache, coupled with good tolerability."

AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilizing a novel Breath Powered delivery technology. If approved, AVP-825 would be the first and only fast-acting, dry-powder intranasal form of sumatriptan for the treatment of migraine.

The Breath Powered delivery technology is activated by user's breath to propel medications deep into the nasal cavity where absorption is more efficient and consistent than through most other routes. A user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity completely. Through a sealing nosepiece placed into the nostril, the exhaled breath carries medication from the device directly into one side of the nose. Narrow nasal passages are gently expanded and medication is dispersed deep into the nasal cavity reaching areas where it can be rapidly absorbed. As the medication is delivered, the air flows around to the opposite side of the nasal cavity and exits through the other nostril.

Closure of the soft palate helps prevent swallowing or inhalation of sumatriptan powder into the lungs.